Randomised controlled trial
A vein bypass first versus a best endovascular treatment first revascularisation strategy for patients with chronic limb threatening ischaemia who required an infra-popliteal, with or without an additional more proximal infra-inguinal revascularisation procedure to restore limb perfusion (BASIL-2): an open-label, randomised, multicentre, phase 3 trial
- Randomised controlled trial
- open-label
- pragmatic
- multicentre
- phase 3
- 41 vascular surgery units in the UK, Sweden and Denmark
- Minimum follow-up 2 years
Authors' conclusion
In the BASIL-2 trial, a best endovascular treatment first revascularisation strategy was associated with a better amputation-free survival, which was largely driven by fewer deaths in the best endovascular treatment group.
Study context
- Population
- Patients with chronic limb-threatening ischaemia due to atherosclerotic disease requiring an infra-popliteal, with or without an additional more proximal infra-inguinal, revascularisation
- Participants
- 345 patients
- Comparison
- Vein bypass first vs best endovascular treatment first
- Vein bypassn = 172
- Best endovascular treatmentn = 173reference
- Primary endpoint
- Amputation-free survival (time to first major [above the ankle] amputation or death from any cause)
Primary result
Major amputation or death
Adjusted hazard ratio
1.35
95% CI 1.02–1.80
P = 0.037
Events by treatment group
Vein bypass vs Best endovascular treatment
adjusted HR 1.35 (95% CI 1.02–1.80); P = 0.037
As reported in the abstract
Further findings
| Outcome | Vein bypass | Best endovascular treatment | adjusted HR (95% CI) | |
|---|---|---|---|---|
| Death | 53% | 45% | 1.37 (1.00–1.87) | |
| 0.512Adjusted hazard ratio (log scale) |
| Outcome | Vein bypass | Best endovascular treatment | Estimate |
|---|---|---|---|
| Cause of death: CV and respiratory · CV and respiratory deaths not mutually exclusive | |||
| CV deaths | 61 | 49 | |
| Respiratory deaths | 25 | 23 |
Original publication
A vein bypass first versus a best endovascular treatment first revascularisation strategy for patients with chronic limb threatening ischaemia who required an infra-popliteal, with or without an additional more proximal infra-inguinal revascularisation procedure to restore limb perfusion (BASIL-2): an open-label, randomised, multicentre, phase 3 trial. Lancet. Published 25 April 2023. doi:10.1016/s0140-6736(23)00462-2
Summarised from the published abstract; every number is checked against it